Angled needle entry

ABSTRACT

An angle assist block for transcutaneous insertion of a needle for a patient is provided. The angle assist block comprises a body portion having an outer surface wherein the outer surface comprises a first side and a second side. The first side is configured to engage skin tissue and the second side opposes the first side. The angle assist block further comprises at least one channel formed through the body portion from the first side to the second side. The channel is angled relative to the first side defining an angle and to allow the needle to be inserted through the channel and transcutaneously introduced at the angle. The angle assist block comprises an attachment portion attached to the outer surface. The attachment portion is configured to removably attach to an attachment receiving member of a tissue visualization device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 61/748,015 filed Dec. 31, 2012, the content of which ishereby incorporated by reference in its entirety.

BACKGROUND

The present invention relates to medical devices. More particularly, theinvention relates to an angled assist block to facilitate transcutaneousinsertion of a needle for a patient.

Currently, to achieve angled entry, many practitioners rely upon theirskill and experience, inserting the needle at the desired anglefreehand. With no measurement taken beforehand, this technique isimprecise and does not lead to reproducible punctures. Practitioners mayalso rely upon a device such as the AXERA Access device to facilitate anangled entry for procedures such as arteriotomy, but these devicesrequire a first puncture step before a second puncture in which angledentry can be performed.

SUMMARY OF THE INVENTION

In overcoming the drawbacks and other limitations of the related art,embodiments of the present invention provide an angle assist block fortranscutaneous insertion of a needle for a patient. In one embodiment,the angle assist block comprises a body portion having an outer surfacewherein the outer surface comprises a first side and a second side. Thefirst side is configured to engage skin tissue and the second sideopposes the first side. The angle assist block further comprises atleast one channel formed through the body portion from the first side tothe second side. The channel is angled relative to the first sidedefining an angle and to allow the needle to be inserted through thechannel and transcutaneously introduced at the angle. Moreover, theangle assist block comprises an attachment portion attached to the outersurface. The attachment portion is configured to removably attach to anattachment receiving member of a tissue visualization device.

Further features and advantages of the present disclosure will becomeapparent from consideration of the following description and theappended claims when taken in connection with the accompanying drawings.It should be understood that the description and specific examples areintended for purposes of illustration only and are not intended to limitthe scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an environmental side view of an angle assist in accordancewith one embodiment of the present invention.

FIG. 2 is a cross-sectional view of the angle assist block in FIG. 1 inaccordance with the principles of the present invention.

FIG. 3 is a perspective view of an angle assist block with multipleneedle entry channels in accordance with another embodiment of thepresent invention.

FIG. 4 is a cross-sectional view of the angle assist block in FIG. 3taken along line 4-4.

FIG. 5 is an environmental side view of an angle assist block inaccordance with another embodiment of the present invention.

FIG. 6 is an environmental side view of an angle assist block inaccordance with yet another embodiment of the present invention.

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present disclosure in any way.

DETAILED DESCRIPTION

The present invention generally provides an angle assist device toassist in angled needle entry to transcutaneously access tissues orvessels beneath the skin. Embodiments of the present invention improvethe accuracy of angled needle entry by providing a needle with a definedangle of entry and by providing means to attach the angle assist deviceto a visualization device.

The terms “substantially” or “about” used herein with reference to aquantity includes variations in the recited quantity that are equivalentto the quantity recited, such as an amount that is equivalent to thequantity recited for an intended purpose or function.

One aspect of this invention is to improve a needle entry step of anytranscutaneous procedure, such as the Seldinger technique. However, theSeldinger technique is cited here only by way of example and it will beappreciated that all possible techniques that can be envisioned asincluding an angled entry step is encompassed in the scope of thisinvention.

An angled needle entry may be the first step in the Seldinger technique.A needle or a trocar is used to puncture the target vessel or cavity. Awire guide is inserted into a lumen of the needle, and the needle iswithdrawn and replaced with another operative device, such as ablunt-ended cannula or a drainage tube. The practitioner may thenproceed with an endoluminal procedure. When the procedure is complete,the assembly is withdrawn and the puncture wound is closed. Depending onthe size of the trocar, the trauma to inner and surface tissues mayrequire extensive sealing after withdrawal. In certain applications ofthe Seldinger technique, the incision may be dilated, further increasingthe size of the area requiring healing and potentially causing excesstrauma, such as hemorrhage or perforation, to any layer of the issue ororgans affected.

One purpose of angled needle entry is to minimize the amount of bleedingresulting from the Seldinger technique. It does so by maximizingtissue-on-tissue overlap, with the points of piercing of each successivelayer of tissue being in contact with intact layers both above (mostproximal to the skin) and below (most distal to the skin). This exposesfewer layers directly to the outside environment and promotesself-healing and clotting. It also minimizes the amount of foreignsealing material required to close the wound and decreases the amount oftime the wound requires to heal.

FIG. 1 illustrates an angle assist device 10 in accordance with oneembodiment of the present invention. As shown, device 10 may include avisualization device 20 and an angle assist block 11. The angle assistblock 11 may work in conjunction with the tissue visualization device 20to allow the practitioner to view subdermal tissue to precisely targetthe tissue while at the same time advancing a needle through the tissueat an angle.

The angle assist block 11 may include a body portion 23 and an outersurface 21. The outer surface 21 may include five sides, including afirst side 12 that opposes a second side 14. The first side 12 may beconfigured to engage (e.g. be in contact with) a patient's skin 32. Inthis embodiment, the first side 12 and the second side 14 may be incontact at edge 15. The outer surface 21 may also include a third side25 which faces the visualization device 20 and may be positioneddirectly between the angle assist block 10 and the visualization device20. The first side 12 and the third side 25 may be in contact at edge26. The second side 14 and the third side 25 may be in contact at edge28. The angle assist block 11 may take on other shapes, including thosehaving one or more sides interposed between the first side 12 and thesecond side 14. The angle assist block 11 may be made of any suitablematerial, including but not limited to hard plastic or metal that issuitable for interaction with a patient's skin during a medicalprocedure.

In this embodiment, the first side 12 may have a substantially flat orflat shape, the second side 14 may have a curved shape, and the thirdside 16 may have a substantially flat or flat shape. However, the firstside 12, the second side 14, and the third side 25 may have othershapes. For example, the second side 14 may be orthogonal orsubstantially orthogonal, parallel or substantially parallel, or at adifferent angle relative to the first side 12. In some embodiments, boththe first side 12 and the second side 14 may be substantially flat orflat and meet at edge 15, and the angle assist block 11 may be in theshape of an five sided block having an inclined plane. In someembodiments, the first side 12 and second side 14 may not meet at edge15, and may instead be connected by an additional side of the outersurface 21. Moreover, the angle assist block 11 can be of any othershape so long as the block 11 has a first side 12 and second side 14. Insome embodiments, the angle assist block 11 may be shaped as atriangular prism.

A channel (e.g. groove) may be formed through and extend through thebody portion 23 (e.g. interior) from an entry hole 17 that may be on thefirst side 12 to an exit hole 27 that may be on the second side 14. Thechannel may be angled relative to the first side 12 and may define anangle with respect to the first side 12 and/or the skin tissue 32. Theneedle may be inserted through the channel and penetrate the skin tissue32 at the angle. The needle may be inserted into entry hole 17, throughthe channel, out of exit hole 27, and transcutaneously inserted through(e.g. penetrate) the skin 32 at entry point 42 into target tissue 40.The target tissue may be any tissue, vessel, cavity, or organ in which aprocedure needs to be performed, for example a vein, an artery, or achest cavity. In some embodiments, grooves may be formed on the outersurface 21 of the angle assist block 11 rather than through the angleassist block 11. For example, In embodiments where the angle assistblock 11 may be a triangular prism, the groove may be cut from or formedon a single side of the outer surface 21 and angled toward the skin 32,and the needle 30 may lie in the groove.

The needle 30 which is shown extending into entry hole 17 can be of anyshape or width desired. It will preferably be made of sterilizable metalbut can be made of any material that is capable of puncturing skin andsubdermal tissue.

Still referring to FIG. 1, the angle assist block 10 may include anattachment portion 18 attached to its outer surface 21. In theembodiment illustrated, the attachment portion 18 may be attached to thesecond side 14, but the attachment portion may be attached to anotherportion of the outer surface 21, for example the first side 12 or thethird side 25. The attachment portion 18 may have an attachment base 29and an attachment loop 19. The attachment base 29 may a substantiallypyramidal shape that attaches the attachment loop 19 to the body portion23. The attachment base 29, attachment loop 19, and body portion 23 maybe integral with each other, formed of the same material, and/or be aone-piece construction. In other embodiments, the attachment base 29,attachment loop 19, and body portion 23 may each be removably attachablefrom each other such that the angle assist block 11 can be usedindependently from the tissue visualization device 20, attachment base29, and attachment loop 19.

The tissue visualization device 20 may be an ultrasound transducer (e.g.ultrasound probe, ultrasound device). The ultrasound transducer may havea frequency range of 10-5 MHz, for example. However, any other devicethat allows a practitioner to view the subcutaneous tissue before,during, and after needle entry can be substituted for an ultrasoundtransducer if desired. Additionally, although the tissue visualizationdevice 20 may, as shown, have an angled L-shape or “hockey stick” shape,any shape of tissue visualization device 20 may be provided andaccommodated by the angle assist device 11. The visualization device 20may be configured to meet the skin 32 at surface 24. The visualizationdevice 20 may include an attachment receiving portion 22 (e.g. acylindrical or tubular shaft) that may be encircled by the attachmentloop 19 of the angle assist block 10. The attachment loop 19 may tightlyencircle the attachment receiving portion 22 to prevent relativemovement between the attachment loop 19 and the attachment receivingportion 22.

Attachment of the angle assist block 11 to the tissue visualizationdevice may be achieved in a number of ways aide from the embodimentdiscussed earlier having an attachment loop 19 and/or an attachment base29. For instance, attachment portion 18 might include of a bolt, whileattachment receiving portion 22 of the tissue visualization device maybe a bolt-receiving groove. The attachment portion 18 might be anadjustable strap that can be tightened around attachment receivingportion 22. The angle assist block and the visualization devices may bemanufactured in such a way that their housings slide together or snaptogether and can be disconnected after use. For example, the attachmentportion 18 may include a tab that lockingly engages a latch of theattachment receiving portion 22 to form a quick-release mount betweenthe angle assist block 11 and the visualization device 20. In anotherexample, the attachment portion 18 may include a surface (e.g. lip) thatis configured to lockingly engage a groove of attachment receivingportion 22. The groove may be a part of a shoe-type connector. In someembodiments, a button may be provided to retract a part of theattachment receiving portion 22 (e.g. tab or shoe-type connector) fromthe attachment portion 18 (e.g. latch or lip). For especially delicateprocedures, the angle assist block 11 might contact the visualizationdevice 20 at multiple attachment points or across an extended surface inorder to impart better stability to the assembly. Each of the attachmentportions 18 may be attached to the third side 25.

Turning now to FIG. 2, a cross-sectional view of the assembly of FIG. 1is illustrated. FIG. 2 shows internal features of angle assist block 11,for example the needle channel 31 and needle exit hole 27. Needle exithole 27 may be formed through the first side 12 of the angle assistblock 11 and may be the portion of the device that enables the needle 30to make contact with and puncture the skin 32. The needle entry channel31 may be formed during the manufacture of the block itself, such as byallowing shapeable plastic to form around a channel-forming object, orthe channel 31 may be created by a method such as drilling or puncturingthe block with an appropriate tool after the angle assist block 11itself has been made.

The needle channel 31 may be angled at an angle 34 relative to the firstside 12 and/or the surface of the skin with the skin 32. The needle mayenter the body at angle 34. The angle 34 may be suitable angle, forexample the angle 34 may depend upon the length of the entry paththrough the target tissue 40 and all tissue layers between the targettissue 40 and the skin 32, as dictated by the procedure. The angle 34may be an acute angle, for example below 90 degrees and above 0 degrees,between about 1 degrees and about 89 degrees, between about 10 degreesand about 80 degrees, between about 15 degrees and about 75 degrees,between about 20 degrees and about 70 degrees, between about 25 degreesand 65 degrees, between about 30 degrees and 60 degrees, between about35 degrees and 55 degrees, between about 40 degrees and 50 degrees, orabout 45 degrees.

The needle channel 31, the needle entry hole 17, and the exit hole 27may be cylindrical in shape, with the needle channel 31 having a smoothinternal surface. In other embodiments, the needle channel 31, theneedle entry hole 17, and the exit hole 27 may be square or rectangular.The needle channel 31 may also have smaller grooves formed into part orall of its length to provide better guidance for the needle 30. Theremay be a multitude of other shapes of the holes and further types ofstriations (e.g. ridges) along the interior of the needle entry channel31 that still fall within the scope of this invention.

FIGS. 3 and 4 illustrate another embodiment of an angle assist device 10which may be similar to the angle assist device of FIGS. 1 and 2.However, in this embodiment, angle assist block 10 may have a pluralityof needle entry holes 17. As illustrated in the cross-sectional view ofFIG. 4, this plurality of entry holes may extend in respective channelswhich may terminate at a single needle exit hole 27 through the firstside 12. In some embodiments, each entry hole 17 may have its owncorresponding exit hole 27. Additionally, in some embodiments, theneedle entry channels may intersect or may be constructed in anon-intersecting fashion. Thus, a single entry hole 17 may lead to asingle or multiple exit holes 27. The needle entry channels may beangled in parallel, substantially parallel, or non-parallel to eachother. The entry holes 17 may be spaced apart and disposed on the secondside 14 along a longitudinal axis that may extend through the edge 15,the third side 25, and/or the visualization device 20 which may beorthogonal or substantially orthogonal to the edge 15. The longitudinalaxis may be coplanar or substantially coplanar with the channels 31. Anangle assist block with multiple needle channels may enable apractitioner to use a single piece of equipment for a variety of tasksinvolving percutaneous procedures. Although three entry holes 17 andthree channels are shown, there may be two, four, five, six, seven,eight, nine, ten, or any number of entry holes 17, two, four, five, six,seven, eight, nine, ten, or any number of channels, two, four, five,six, seven, eight, nine, ten, or any number of exit holes 27 .

FIG. 5 illustrates yet another embodiment of this invention which may besimilar to the embodiment of FIGS. 3 and 4. However, this embodiment mayinclude multiple needle entry holes 17 that may be spaced apart anddisposed on the second side 14 along a longitudinal axis that may beparallel or substantially parallel to the edge 15. The longitudinal axismay be coplanar or substantially coplanar with the channels 31. Thisembodiment may be used when multiple punctures may be made to a targettissue at different points along the length of the target tissue, orwhen multiple subcutaneous structures may be accessed. Although only twoneedle entry holes 17 are illustrated here, it will be understood thatthe number of needle entry holes may be limited only by the size of theangle assist block itself and the diameter of the channels required tofit the needle therein. For example, although two entry holes 17, twochannels, and two exit holes 27 are shown, there may be three, four,five, six, seven, eight, nine, ten, or any number of entry holes 17,three, four, five, six, seven, eight, nine, ten, or any number ofchannels, three, four, five, six, seven, eight, nine, ten, or any numberof exit holes 27.

Additionally, although the embodiments of FIGS. 3-5 show entry holes 17disposed along a single longitudinal axis, the entry holes 17, channels31, and exit holes 19 may be spaced apart along both longitudinal axes(e.g. two orthogonal longitudinal axes) such that they form a grid ofentry holes 17, channels 31 (some or all of which may be parallel orsubstantially parallel, for example), and exit holes 27. For example,the grid may be a 2×2 grid or 3×3 grid.

FIGS. 1-5 illustrate some possible relative positioning schemes for theangle assist block 11 relative to the tissue visualization device 20.However, other relative positioning schemes may be implemented. Forexample, an attachment receiving point of the attachment receivingportion 22 may be a single point, or may run down the entire contactingsurfaces of both the attachment portion 18 and the attachment receivingportion 22. If the angle assist block 11 or the visualization device 20have a first set of edges that are narrower than a second set of edges(e.g. where the second set of edges are orthogonal or substantiallyorthogonal to the first set of edges), or both, then a narrower edge ofthe angle assist block 11 may face and/or contact a narrow edge of thetissue visualization device 20 as in FIG. 1, or a wider edge of theangle assist block 11 may face and/or contact a wider edge of the tissuevisualization device 20 as in FIG. 5. In some embodiments, a wider edgemay face and/or contact a narrower edge. There may be a plurality ofcontacts made between the angle assist block 11 and the tissuevisualization device 20, or there may be just a single contact. Theremay be any number of spaces between the block 11 and the visualizationdevice 20, or the two may be completely integral with each other alongthe sides at which they meet.

Turning now to FIG. 6, yet another embodiment of the invention isillustrated. This embodiment may be similar to the embodiments of FIG.1-5. However, in this embodiment, the angle assist block portion 11 andthe tissue visualization device 20 may be components assembled within asingle housing 60 and may therefore be integral with each other, made ofthe same material as each other, and/or may be formed of a one-piececonstruction with each other. Although the housing 60 may be a singlehousing 60, this embodiment may also encompass any attachment of anirreversible or difficult-to-reverse nature, such as welding, soldering,gluing, and the like.

The outer housing 60 of the device of this embodiment may be made of anysuitable material that may not interfere with the operation of thetissue visualization device 20 housed within, including various plasticsor metals or a combination thereof. The options for configuring theangle assist block portion of this unified device may encompass theoptions contemplated in the embodiments of FIG. 1-5. For example, aplurality of needle exit holes 27 and entry holes 17 may be formedthrough the first side 12 and second side 12, respectively. The channels31 may be formed at a variety of angles or identical or substantiallyidentical angles, and may intersect or not intersect. The shapes of theholes 17 and 27 and the channels 31, as well as their diameters,lengths, and depths, may be varied as well, in accordance with theneedles or trocars intended to be used in the application for which thedevice is designed.

As a person skilled in the art will readily appreciate, the abovedescription is meant as an illustration of implementation of theprinciples of this invention. This description is not intended to limitthe scope or application of this invention in that the invention issusceptible to modification, variation and change, without departingfrom the spirit of this invention, as defined in the following claims.

1. An angle assist block for transcutaneous insertion of a needle for apatient, the angle assist block comprising: a body portion having anouter surface, the outer surface comprising a first side and a secondside, the first side being configured to engage skin tissue, the secondside opposing the first side; at least one channel formed through thebody portion from the first side to the second side, the channel beingangled relative to the first side defining an angle and to allow theneedle to be inserted through the channel and transcutaneouslyintroduced through the skin tissue at the angle; and an attachmentportion attached to the outer surface, the attachment portion beingconfigured to removably attach to an attachment receiving portion of atissue visualization device.
 2. The angle assist block of claim 1wherein the tissue visualization device comprises an ultrasoundtransducer.
 3. The angle assist block of claim 1 wherein the attachmentportion comprises a clamp, and wherein the attachment receiving portioncomprises a clamp-receiving portion.
 4. The angle assist block of claim1 wherein the attachment portion comprises a bolt, and wherein theattachment receiving portion comprises a bolt-receiving portion.
 5. Theangle assist block of claim 1 wherein the attachment portion comprises astrap, and wherein the attachment receiving portion comprises astrap-receiving portion.
 6. The angle assist block of claim 1 whereinthe attachment portion comprises a receiving loop having an innerdiameter through which the attachment receiving portion of thevisualization device extends.
 7. The angle assist block of claim 1wherein the at least one channel comprises a plurality of channels. 8.The angle assist block of claim 7 wherein the angle of a first channelof the plurality of channels is substantially identical to an angle of asecond channel of the plurality of channels.
 9. The angle assist deviceof claim 7 wherein the angle of a first channel of the plurality ofchannels is different relative an angle of a second channel of theplurality of channels.
 10. The angle assist device of claim 1 whereinthe first side and the second side share an edge.
 11. The angle assistdevice of claim 1 wherein the first side and the second side do share anedge.
 12. An apparatus comprising: a tissue visualization device havingan attachment receiving portion; and an angle assist block comprising: abody portion having an outer surface, the outer surface comprising afirst side and a second side, the first side being configured to engageskin tissue, the second side opposing the first side, the body portionbeing integral with the tissue visualization device; at least onechannel formed through the body portion from the first side to thesecond side, the channel being angled relative to the first sidedefining an angle and to allow the needle to be inserted through thechannel and transcutaneously introduced penetrate the skin tissue at theangle.
 13. The apparatus of claim 12 wherein the tissue visualizationdevice comprises an ultrasound transducer.
 14. The apparatus of claim 12further comprising an exterior housing, wherein the tissue visualizationdevice and the body portion are formed of the exterior housing.
 15. Theapparatus of claim 12 wherein the at least one channel comprises aplurality of channels.
 16. The apparatus of claim 12 wherein the angleof a first channel of the plurality of channels is substantiallyidentical to an angle of a second channel of the plurality of channels.17. The apparatus of claim 12 wherein the angle of a first channel ofthe plurality of channels is different relative an angle of a secondchannel of the plurality of channels.
 18. The apparatus of claim 17wherein the first side and the second side share an edge.
 19. Theapparatus of claim 17 wherein the first side and the second side doshare an edge.
 20. A method of using an angle assist block and avisualization device, the angle assist block comprising a body portionhaving an outer surface, the outer surface comprising a first side and asecond side, the first side being configured to engage skin tissue, thesecond side opposing the first side, the angle assist block furthercomprising at least one channel formed through the body portion from thefirst side to the second side, the channel being angled relative to thefirst side defining an angle, the angle assist block further comprisingan attachment portion attached to the outer surface, the attachmentportion being configured to removably attach to an attachment receivingportion of the visualization device, the method comprising: providing aview of internal body tissue with the visualization device; inserting aneedle through the channel; and while providing the view of the internalbody tissue, transcutaneously introducing the needle through the skintissue at the angle.